Manager - Engineering (Utility Services)

Review

• To provide assistance for preparing and reviewing the validation and engineering related Standing Operating Procedure;
• To review/update the master plan for validation based on current regulatory requirements
• To review, approve and provide the required assistance or preparation of qualification protocols

Technical Support

• To plan and supervise utility installation and commissioning
• Adhere to the utility budget & time lines
• Assist for initial estimation of maintenance cost based on activity and cost control for all the annual budgeting
• Responsible to use thorough knowledge of Engineering maintenance practice including budgeting, scheduling, preventive maintenance, specification codes, Standard and cGMP techniques. Improvement in reliability where ever applicable in utility machines & systems
• To coordinate for closure of change control in the engineering and validation department.
• Troubleshooting during validation activities

Compliance & Audit

• 100% regulatory compliance by maintaining all cGMP documents, including SOPs and PM records
• 100% statutory compliance of utilities
• To represent Utility section during regulatory audits

Maintenance & Control

• To review proper maintenance of ETP & Utility at site
• Timely maintenance and optimize machine operation of utilities
• Timely completion of maintenance by adhering to both budget & time lines & safety norms
• Responsible for accurate parts inventory and equipment specific usage control
• Responsible to ensure speedy and timely completion of implementation of all maintenance in house program.